OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTIONAug 14, 2013 · 372-5 UNITED STATES...

372-5

UNITED STATES ENVIRONMENTAL PROTECTION AGENCYWASHINGTON, D.C. 20460

AU6 1 4 2013

OFFICE OF CHEMICAL SAFETYAND POLLUTION PREVENTION

Julie TimbermanSr. Regulatory ScientistClorox Professional Products Companyc/o PS&RC; P.O. Box 493Pleasanton, CA 94566-0803

Subject: Dispatch® Hospital Cleaner Disinfectant Towels with BleachEPA Registration No.: 56392-8Application Date: 04/16/2013EPA Receipt Date: 04/19/2013

Dear Ms. Timberman:

The following amendment submitted in connection with registration under FIFRA, as amended, isacceptable.

Proposed Amendment

• Addition of Home Healthcare language along with minor label revisions• Alternate Brand Names:

o Clorox® CareConcepts™ Germicidal Bleach WipesTN/fo CareConcepts Germicidal Bleach Wipes

o Remeda Germicidal Bleach Wipeso Clorox® CareConcepts™ Disinfecting Bleach Wipeso CareConcepts™ Disinfecting Bleach Wipeso Remeda Disinfecting Bleach Wipeso Clorox® CareConcepts™ Germ Control Kit (containing Clorox® CareConcepts™

Germicidal Bleach Wipes)o CareConcepts™ Germ Control Kit (containing CareConcepts™ Germicidal Bleach

Wipes)o Remeda Germ Control Kit (containing Remeda Germicidal Bleach Wipes)o Clorox® CareConcepts™ Germ Control Kit (containing Clorox® CareConcepts™

Disinfecting Bleach Wipes)o CareConcepts™ Germ Control Kit (containing CareConcepts™ Disinfecting Bleach

Wipeso Remeda Germ Control Kit (containing Remeda Disinfecting Bleach Wipes)o Clorox® CareConcepts™ Germ Disinfection Kit (containing Clorox® CareConcepts™

Germicidal Bleach Wipes)o CareConcepts™ Germ Disinfection Kit (containing CareConcepts™ Germicidal Bleach

Wipes)

o Remeda Germ Disinfection Kit (containing Remeda Germicidal Bleach Wipes)o Clorox® CareConcepts™ Germ Disinfection Kit (containing Clorox® CareConcepts™

Disinfecting Bleach Wipes)o CareConcepts™ Germ Disinfection Kit (containing CareConcepts™ Disinfecting Bleach

Wipeso Remeda Germ Disinfection Kit (containing Remeda Disinfecting Bleach Wipes)

General Comments

A stamped accepted label with conditions is enclosed for your records. This labeling supersedes allprevious labeling. The next printing of this product must use this labeling unless subsequent changes have beenapproved. You must submit one copy of the final printed label before selling or distributing the product bearingthe revised labeling. In accordance with 40 CFR 152.130(c), you may distribute or sell this product under thepreviously approved labeling for 18 months from the date of this letter. After 18 months, you may only distributeor sell this product if it bears this new revised labeling, or subsequently approved labeling. "To distribute or sell"is defined under FIFRA section 2(gg) and it's implementing regulation at 40 CFR 152.3.

Should you have any questions or comments concerning this letter, you may contact Jaclyn Pyne bytelephone at (703) 347-0213 or by e-mail at [email protected]. When submitting information or data inresponse to this letter, a copy of this letter should accompany the submission to facilitate processing.

Demson FullerActing Product Manager (32)Regulatory Management Branch IIAntimicrobials Division (751 OP)

fUNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C. 20460

AU6 1 4 2013

OFFICE OF CHEMICAL SAFETYAND POLLUTION PREVENTION

Julie TimbermanSr. Regulatory ScientistClorox Professional Products Companyc/o PS&RC; P.O. Box 493Pleasanton, CA 94566-0803

Subject: Clorox Home Health Care Concepts KitsEPA Registration Nos: 5813-105, 56392-8, 67619-26

Dear Ms. Timberman:

This correspondence is to acknowledge the kit language and formatting with the stampedlabels dated August 14, 2013 for the registrations referenced above. The placement of theingredient statement on kit packaging is acceptable on the back panel with the rest of theproduct-specific information. The kit graphics and inserts have been reviewed by EPA forconsistency with the master label, even though they will not be stamped as part of the label. Thekit itself does not need its own registration and EPA allows registrants the option of usingalternate brand names for each of the existing registrations of the products inside the kit. Eachalternate brand name identifies the product as part of the kit, but is unique.

Should you have any questions or comments concerning this letter, you may contactJaclyn Pyne by telephone at (703) 347-0213 or by e-mail at [email protected]. Whensubmitting information or data in response to this letter, a copy of this letter should accompanythe submission to facilitate processing.

Sine

Demson'FullerActing Product Manager (32)Regulatory Management Branch IIAntimicrobials Division (751 OP)

Note: Bold, italicized text is information for the rearjn, andisnot part of the label.[Bracketed information is optional text.] Green underlined text is new. Strike-through(text) means removed. Optional text may be placed anywhere on the label/container.R0887059_clean_Rosie

r EPA Reg. Mo. 56392-8 Dispatch® Hospital CleanerDisinfectant Towels with Bleach

Pagel of 18

DISPATCHospital Cleaner Disinfectant Towels with Bleach

KEEP OUT OF REACH OF CHILDRENCAUTIONNOT TO BE USED AS BABY WIPESKEEP PACKAGE -OR- CONTAINER TIGHTLY SEALED WHEN NOT IN USERead Complete Directions and Precautions on Back -or- side -or- rear[Panelfs]] [Dispenser Carton]SELECT A SIZE (For Canister Only]

[Net] [Contents] [# of towels and size and weight]Each package type and size will bear the actual net contents inpounds and ounces

Active Ingredient:Sodium Hypochlorite 0.65%Other Ingredients 99.35%Total . 100.00%(yields 0.62% available chlorine)

ACCEPTED14

UnrJerttie Federal Insatfkxte. c'ingicide,andRodenticide Act as aT.-rrfed for thepesticide,regist=red under i -

• [Contains 6500 ppm Sodium Hypochlorite]• [Cleans [and], Disinfects, [& Deodorizes] in One Step]• [Kills [99.99% of] bacteria, virusesf & fungi in 1 Minute on Hard, Nonporous Surfaces]• [Kills Pandemic 2009 H1N1 Influenza A Virus]• [Kills Clostridium difficile [spores] in 5 Minutes [on Precleaned, Hard, Nonporous Surfaces][*],W• [Peel and Reseal Here for flex packs only]• [Pre-Moistened Towels with 1:10 Dilution of Bleach [(6.0%)] and Detergent]

Kills [99.99% of] bacteria, viruses! & fungi in 1 Minute [on Hard Non-Porous Surfaces], [(see rear panel)]: Acinetobacter baumannii,fAvian Influenza A Virus, fCanine Parvovirus, Enterobacter aerogenes, Escherichia coli ESBL, fFeline Panleukopenia Virus, fHepatitis AVirus (HAV), fHepatitis B Virus (HBV)W, fHepatitis C Virus (HCV)W, fHerpes Simplex Virus (HSV-2), tHIV-1 (AIDS Virus)W, flnfluenzaA H1N1 [2009] [Pandemic], flnfluenza A Virus, Klebsiella pneumoniae, [Methicillin resistant] Staphylococcus aureus (MRSA), fNorovirus,tPoliovirus Type 1 (Mahoney), Pseudomonas aeruginosa, fRhinovirus, fRotavirus, Salmonella enterica tested as Salmonella choleraesuis,Staphylococcus aureus, Streptococcus pyogenes, Trichophyton mentagrophytes (Athlete's Foot Fungus), [Vancomycin resistant] Enterococcusfaecalis (VRE)

Kills Mycobacterium bovis- BCG, (TB) in 2 MinutesKills Clostridium difficileW [spores] in 5 minutes [on Precleaned, Hard, Nonporous Surfaces ][*]Manufactured for:© XXXX Clbrox Professional Products Company1221 Broadway, Oakland, CA94612[QUESTIONS OR COMMENTS?] [Call] 800-234-7700[Visit us at -or- For MSDS information, [please] go to] www.cloroxprofessional.comA list of this product's ingredients is available at www.lngredientslnside.com -or-A list of [this product's] [product name] ingredients is available at[insert company website].Clorox is a registered trademark of the Clorox Companyinsert trademarkIs a [registered] trademark of Clorox Professional Products Company

ttt Note to reviewer: not to be included for "Home Healthcare " product or kit labeling

EPA Reg. No. 56392-8EPAEst. No. 8251-OH-1 (Q6);5813-GA-2(VG); IL-2 (VF)Beginning of batch code indicates Est. No.

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Note: Bold, italicized text is information for the reaiic. and is not part of the label. - EPA Reg. No. 56392-8 Dispatch® Hospital Cleaner'[Bracketed information is optional text.] Green underlined text is new. Strike-through Disinfectant Towels with Bleach(test) means removed. Optional text may be placed anywhere on the label/container. Page 2 of 18R0887059 clean_Rosie

PRECAUTIONARY STATEMENTS: Hazards to humans and domestic animals.CAUTION:Causes moderate eye irritation. Avoid contact with eyes or clothing. Wash thoroughly with soap and water after handling and before eating,drinking, chewing gum, using tobacco, or using the toilet.

FIRST AID:If in eyes, hold eye open and rinse slowly and gently with water for 15-20 minutes. If present, remove contact lenses after the first 5 minutesof rinsing, then continue rinsing eye. Call a poison control center or doctor for further treatment advice. Have the product container or labelwith you when calling a poison control center or doctor, or going for treatment. [Emergency Information: 1-800-446-1014. -or- Poison ControlCenter: (800) 446-1014 -or- Clorox Information Line: 1-888-797-7225 -or- Questions? Call 1-888-797-7225.]

PHYSICAL OR CHEMICAL HAZARDSDo not use this product with ammonia or acids such as vinegar, rust removers, or toilet bowl cleaners.

STORAGE AND DISPOSAL:For canistersStore this product in a cool, dry area away from direct sunlight and heat. When not in use keep center cap of lid closed to prevent moisture loss.Nonrefillable container. Do not reuse or refill this container. Discard used towels and container in trash or take container to recycling center. [Donot flush towels down toilet.]

For soft packs and individually wrapped packsStore this product in a cool, dry area away from direct sunlight and heat. Nonrefillable container. Do not reuse or refill this container. Discardused towel and empty package in trash. [Do not flush towels down toilet]

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Note: Bold, italicized text is information for the real .nt is not part of the label.[Bracketed information is optional text.] Green underlined text is new. Strike-through(tot) means removed. Optional text may be placed anywhere on the label/container.R0887059_clean_Rosie

EPA Reg. No. 56392-8 Dispatch® Hospital GleamDisinfectant Towels with Bleach

Page 3 of 18

iklangr

Packaging Related Statements

For fold-pack labels:Peel for [here] [additional] directions [for use][.]

Dispenser:CanisterTo open: Remove lid. Discard inner seal from canister.To thread: Find center of wipe roll, twist corner of first wipe into a point and thread through the hole in the canister lid. Pull through about oneinch. Replace lid. Dispense remaining wipes as necessary by pulling out and tearing off. When not in use, keep center cap of lid closed toprevent moisture loss.

Select-A-Size: For a 7"x 8" towel - pull one towel gently through the hole, angle sharply and detach at the first perforation. For a 7" x 16" towel -pull two towels gently straight up through the hole. Hold second towel, angle sharply and detach at the second perforation. NOTE: Select-A-Sizefeature for the larger size towel works best after several smaller towels have been used.

Soft packOpen package. Pull out wipes as needed and reseal. When not in use keep sealed to prevent moisture loss.

Individually wrapped PackTear open packet. Unfold.

RESEAL HEREPULL TABRemove [flaps] [lid] to create dispenser.

REORDER NO.See expiration date [on package].

[This is not a baby wipe] [Not for personal use.]

Pre-moistened disposable towels for use in healthcare and other areas where control of cross contamination is required. Meets OSHABloodborne Pathogen Standards. Surfaces: For use on hard, non porous surfaces such as stainless steel, glazed ceramic tile, hard plastics,nonporous vinyl, painted surfaces, glazed porcelain, sealed fiberglass surfaces, Plexiglas[®]1, laminated plastic countertops, and glass. [Thisproduct [is] not intended for use on fabrics.]1Plexiglas is a [registered] trademark of [Arkema, Inc.] [a subsidiary of] [Arkema, Inc.] [or one or more of its affiliates].

Use Sites [Hospitals, Healthcare, and Home Healthcare]:Hospital and Healthcare: Clinics, Dental offices, Emergency rooms (ER), Hospitals, Hospital central service areas, Intensive Care Units (ICU),Laboratory, Nursing homes, Physical therapy, Physician offices, Radiology, Recovery rooms and Surgery.Critical Care Areas: ER, ICU, Neonatal Intensive Care Units (NICU), Pediatric Intensive Care Units (PICU) and Surgery.Applications: Hard, nonporous surfaces such as autoclaves, bed railings, blood glucose monitors, cabinets, carts, chairs, counters, examtables, gurneys, infant incubators and care cribs, IV poles, phlebotomy trays, plastic mattress covers, PVC tubing, stretchers, tables, ambulanceequipment, diagnostic equipment, dialysis machines, mammography equipment, patient monitoring equipment, respiratory equipment,ultrasound transducers and probes, and wheelchairs.Nursery or Oaycare Centers: Changing tables, cribs, trash cans, toys and other hard, nonporous surfaces listed on this label.

Optional graphics. May be placedanywhere on label/container.


rNote: Bold, italicized text is information for the reau*. and is not part of the label.

[Bracketed information is optional text.] Green underlined text is new. Strike-through(text) means removed. Optional text may be placed anywhere on the label/container.R0887059 clean_Rosie

rEPA Reg. No. 56392-8 Dispatch® Hospital Cleaned

Disinfectant Towels with BleachPage 4 of 18

DIRECTIONS FOR USE:It is a violation of Federal Law to use this product in a manner inconsistent with its labeling.

Dispenser directions:Canister directionsTo open; Remove lid. Discard inner seal from canister.To thread: Find center of wipe roll, twist corner of first wipe into a point and thread through the hole in the canister lid. Pull through aboutone inch. Replace lid. Dispense remaining wipes as necessary by pulling out and tearing off. When not in use, keep center cap of lid closed toprevent moisture loss. Gloves should be worn.

Select-A-Size: For a 7"x 8" towel - pull one towel gently through the hole, angle sharply and detach at the first perforation. For a 7" x 16" towel -pull two towels gently straight up through the hole. Hold second towel, angle sharply and detach at the second perforation. NOTE: Select-A-Sizefeature for the larger size towel works best after several smaller towels have been used.

Soft pack directionOpen package. Pull out wipes as needed and reseal. When not in use keep sealed to prevent moisture loss. Gloves should be worn.

Individually wrapped Pack directionsTear open packet. Unfold and use as directed. Discard after single use. Gloves should be worn.

To Clean, Disinfect, and Deodorize in One Step: Wipe surface with towel until completely wet. Let stand for one minute. To kill TB, let standfor two minutes at room temperature (20 - 25°C -or- 68 - 77° F). Wipe dry or allow to air dry. Gross soil must be removed prior to disinfecting.Gloves should be worn.

To Clean: Follow directions above, but no standing time is required. If streaking is observed, wipe with a clean, damp cloth or paper towel.


rNote: Bold, italicized text is information for the reaoei and is not part of the label.[Bracketed information is optional text.] Green underlined text is new. Strike-through(text) means removed. Optional text may be placed anywhere on the label/container.R0887059_clean_Rosie

EPA Reg. No. 56392-8 Dispatch® Hospital CleanerDisinfectant Towels with Bleach

Page 5 of 18

*Special Instructions for Cleaning Prior to Disinfection against Clostridium difficile^ spores. Personal Protection: Wear appropriatebarrier protection such as gloves, gowns, masks, or eye covering. Cleaning Procedure: Fecal matter/waste must be thoroughly cleaned fromsurfaces/objects before disinfection by application with [Product Name] [this product]. Cleaning is to include vigorous wiping and/or scrubbing,until all visible soil is removed. Special attention is needed for high-touch surfaces. Surfaces in patient rooms are to be cleaned in an appropriatemanner, such as from right to left or left to right, on horizontal surfaces, and top to bottom, on vertical surfaces, to minimize spreading of thespores. Restrooms are to be cleaned last. Do not reuse soiled cloths. Infectious Materials Disposal: Materials used in the cleaning process thatmay contain feces/wastes are to be disposed of immediately in accordance with local regulations for infectious materials disposal.Disinfection Procedure: Wipe surface with towel until completely wet. Let stand for five minutes. Wipe dry or allow to air dry. Gross soil mustbe removed prior to disinfecting. Gloves must be worn.

Ultrasound transducers and probes:**For use on external surfaces of ultrasound transducers and probes only.To disinfect: Pre-clean gel from external surface of ultrasound transducer or probe to be disinfected with a paper towel or clean cloth. Thenthoroughly wet the probe with a [Product Name] towel. Let stand for one minute. To kill TB, let stand for two minutes at room temperature.

tKILLS HIVftf, HBVfff and HCVW ON PRECLEANED ENVIRONMENTAL SURFACES/OBJECTS PREVIOUSLY SOILED WITH BLOOD/BODYFLUIDS in healthcare settings or other settings in which there is an expected likelihood of soiling of inanimate surfaces/objects with blood/body fluids, and in which the surfaces/objects likely to be soiled with blood/body fluids can be associated with the potential for transmission ofHuman Immunodeficiency Virus Type 1 (HIV-1)W (associated with AIDS), Hepatitis B Virus (HBV)W, and Hepatitis C Virus (HCV)WSpecial Instructions for Cleaning and Decontamination Against HIV-1 (AIDS Virus), HBV and HCV on Surfaces/Objects Soiled with Blood/Body Fluids. : When handling items soiled with blood/body fluids, personal protective equipment such as disposable gloves, gowns, masks,and eye coverings must be used. Cleaning Procedure: Blood/body fluids must be thoroughly cleaned from surfaces and objects beforedisinfecting. Contact Time: Let stand for one minute. Disposal of Infectious Materials: Blood, body fluids, and cleaning materials must beautoclaved and disposed according to federal, state, and local regulations for infectious waste disposal.

NOTE TO REVIEWER: This statement to be used on institutional labels with medical use sites, medical devicesand/or bloodborne pathogens:**This product is not to be used as a terminal sterilant/high level disinfectant on any surface or instrument that (1) is introduced directly intothe human body, either into or in contact with the bloodstream or normally sterile areas of the body, or (2) contacts intact mucous membranesbut which does not ordinarily penetrate the blood barrier or otherwise enter normally sterile areas of the body. This product may be used topreclean or decontaminate critical or semi-critical medical devices prior to sterilization or high level disinfection.

tttNote to reviewer: not to be included for "Home Healthcare " product or kit labeling


Note: SoW, italicized text is information for the reai~. and is not part of the label.[Bracketed information is optional text.] Green underlined text is new. Strike-through(text) means removed. Optional text may be placed anywhere on the label/container.R0887059_clean_Rosie

c EPA Reg. No. 56392-8 Dispatch® Hospital CleanerDisinfectant Towels with Bleach

Page 6 of 18

Optional Claims. They may be placed anywhere on label/container.Now -and/or- New [!] and -or- & Improved [!] to be used as a claim descriptor only lor the first 6 months of product on shelL

• A potable water rinse is required for food contact surfaces.• A solution impregnated in a wiping cloth• An effective method to clean, deodorize and disinfect against odor-

causing organisms on hard, nonporous surfaces listed on this label.• An effective way to disinfect hard, nonporous environmentalsurfaces listed on this label.

1 Antibacterial formula1 [Appropriate] [Perfect] [Ideal] [for] Terminal Cleaning Patient

Discharge[s] [ing]• Attacks and kills [Clostridium difficile] [C. difficile] [C. diff] [(C.

diff)] W [spores] [on precleaned, hard, nonporous surfaces] [*].• [Bactericidal] [Tuberculocidal] [Virucidalf] [Fungicidal -or-

antifungal] [Sporicidal] [Disinfectant].• Broad Spectrum Disinfectant• Cleans, disinfects and deodorizes• Convenient• Delivers consistent [amount of solution] concentration everytime[!]

• Designed for killing [Clostridium difficile] [C. difficile] [C. diff][(C. diff)]ttt [spores] [*] [on precleaned, hard, nonporoussurfaces] in hospitals.

• Designed for the Medical/Dental/Health Care industry• [Designed] [for] [with] [the] Environmental ServicesProfessionals] [in] [mind] [!]

1 [Destroys] [Deactivates] [[Helps] Eliminate] [tough-to-kill][Clostridium difficile] [C. difficile] [C. diff] [(C. diff)]ttt [spores] [onprecleaned hospital surfaces ] [*].

• Disinfectant• Disinfects hard, nonporous environmental surfaces listed on thislabel

• Disposable1 Do not use on glassware, utensils or dishes.1 Does not produce mist or overspray• Easy and convenient to use'Easyto handle1 Effective against [Influenza A H1IM1] [H1N1] [insert any organismfrom the list on page 1] [and] [C. difficile spores] [on precleaned,hard, nonporous surfaces] [*].

• Effective against [insert any organism from list of organisms][and] [Clostridium difficile] [C. difficile] [C. diff] [(C. diff)]W[spores] [on precleaned, hard, nonporous surfaces] [*].

1 Effective against Avian Influenza A and H1N1 [Pandemic] [InfluenzaA virus].

• [Effective] [For daily use against] [Clostridium difficile] [C. difficile][C. diff] [(C. diff)] ttt [spores] [on precleaned, hard, nonporoussurfaces] [*].

1 [Efficacy tests have demonstrated that [Product Name] [thisproduct] [are] [is] an effective bactericide, virucidet, tuberculocide,and fungicide in the presence of organic soil (5% blood serum)]

> Eliminates airborne particles associated with sprays1 Eliminates [daily] mixing and measuring1 EVS [Environmental Services]1 [For] general use

• For use on bathroom surfaces• For use on nursery surfaces• Formulated to kill [Clostridium difficile] [C. difficile] [C. diff] [(C.

diff)] W [sPores] [*] [°n precleaned, hard, nonporous surfaces][when used according to instructions].

• Fresh lingering bleach scent• Fungicidal -or- antifungal• [Heavy] cloth-like towel• Institutional [size]• Kills [bacteria] [viruses] [fungi] [C. difficile spores] [on precleaned,

hard, nonporous surfaces] [*].• Kills [bacteria] [viruses] [fungi] [Clostridium difficile] [C. difficile]

[C. diff] [(C. diff)]ttt [spores] [*].• Kills [Clostridium difficile] [C. difficile] [C. diff] [(C. diff)]tff

[spores] in 5 Minutes [*] [on precleaned, hard, nonporoussurfaces].

• Kills [Clostridium difficile] [C. difficile] [C. diff] [(C. diff)]W[spores] [*] [on precleaned, hard, nonporous surfaces] [when usedaccording to instructions].

• [Kills] [Is effective against] 99.9999% of [Clostridium difficile][C. difficile] ttt spores in 5 [minutes] [min] [on precleaned, hard,nonporous surfaces] [*].

• [Kills] [Is effective against] [99.9999% of] [Clostridium difficile][C. difficile] [C. diff] [(C. diff)]ttt [spores] [in 5 [minutes] [min]][*] [on precleaned, hard, nonporous surfaces].

• Kills microbes, including the spore form of [Clostridium difficile][C. difficile] [C. diff] [(C. diff)]ttt [spores] [*] [on precleaned, hard,nonporous surfaces].

• Largefr] Surface[s]• Larger wipe covers [more surface area] [larger area] [with less

effort] [!]• No measuring• No mixing• Not formulated to contain mercury• [Passes] [Meets] [Satisfies] [EPA] requirements for killing

[Clostridium difficile] [C. difficile] ttt spores [on precleaned, hard,nonporous surfaces] [*].

• Pre-measured• Premoistened• Prevents formulation errors• [Product Name] are intended for cleaning and disinfecting hard,

nonporous surfaces where control of cross-contamination isrequired.

• [Product Name] are pre-moistened with a unique, stabilized bleachand detergent solution and are ready-to-use.

• [Product Name] are useful in a variety of healthcare and nursery/daycare applications listed on the [this] label.

• [Product Name] may be used to clean and disinfect in one step;see directions for use on this label for cleaning and disinfectingin one step.

• Ready to U[u]se

ttt note to reviewer: not to be included for "Home Healthcare "product or kit labeling


Note: Bold, italicized text is information for the reatiei and is not part ot the label.[Bracketed information is optional text.] Green underlined text is new. Strike-through(tod) means removed. Optional text may be placed anywhere on the label/container.R0887059_clean_Rosie

cEPA Reg. Mo. 56392-8 Dispatch® Hospital Clean


Optional Claims. They may be placed anywhere on label/container, continuedNow -and/or- New [!] and -or- & Improved [!] to be used as a claim descriptor only for the first 6 months of product on shelf.

1 Ready-to-use disinfectant [disinfection] for [killing] [Clostridiumdifficile] [C. difficile] [C. diff] [(C. diff)] W [spores] [*] [onprecleaned, hard, nonporous surfaces].

• Renders [Clostridium difficile] [C. difficile] [C. diff] [(C. m)]ttt[spores] inactive[*] [on precleaned, hard, nonporous surfaces].

1 Respiratory illnesses attributable to Pandemic 2009 H1N1 arecaused by influenza A virus. [This product] [Product Name] is abroad-spectrum hard surface disinfectant that has been shownto be effective against (influenza A virus tested and listed on thelabel) and is expected to inactivate all influenza A viruses includingPandemic 2009 H1N1 (formerly called swine flu).

1 Shelf-stable formula1 [Strong,] [Durable,] cloth-like wipes1 [Strong,] [Durable,] non-woven disposable cloth1 [Strong,] [Durable,] non-woven wipe does not leave lint onsurfaces [following use]

1 Suitable for hospital use• Suitable for use on [titanium-coated] [medical grade] stainless steel• Suitable for use on hard, nonporous inanimate environmentalsurfaces

• Suitable for use on insert surface material(s) listed• [The] smell of clean1 [This product] [Product Name] has demonstrated effectivenessagainst influenza A virus and is expected to inactivate all influenza Aviruses including Pandemic 2009 H1N1 influenza A virus.

• [This product] [Product Name] has demonstrated effectivenessagainst (influenza A virus tested and listed on the label) and isexpected to inactivate all influenza A viruses including Pandemic2009 H1 I\I1 (formerly called swine flu).

• To break down and kill [inactivate] [help prevent the spread of][Clostridium difficile] [C. difficile] [C. diff] [(C. diff)]ttt [spores] [onsurfaces] [*] [on precleaned, hard, nonporous surfaces].

• To decontaminate [Clostridium difficile] [C. difficile] [C. diff][(C. diff)]ftf [spores] [on precleaned, hard, nonporous] ladensurfaces [*].

• To fight [Clostridium difficile] [C. difficile] [C. diff] [(C. diff)][spores] W[onprecleaned, hard, nonporous surfaces] [*].

• To kill [Clostridium difficile] [C. difficile] [C. diff] [(C. diff)]ttt[spores] [on precleaned, hard, nonporous surfaces] [*], [let standfor fiveminutes].

•To reduce [Clostridium difficile] [C. difficile] [C. diff] [(C. diff)]W[spores] on [precleaned, hard, nonporous] surfaces in insert fromuse sites listed [*].

•To reduce transmission of [Clostridium difficile] [C. difficile][C. diff] [(C. diff)]ttt [spores] [on precleaned, hard, nonporoussurfaces] [*].

ttt note to reviewer: not to be included for "Home Healthcare"product or kit labeling


,fNote: Bold, italicized text is information for the re\ md is not part of the label.[Bracketed information is optional text.] Green'uhderlined text is new. Strike-through(text) means removed. Optional text may be placed anywhere on the label/container.R0887059_clean_Rosie

r l Cleane' 'lEPA Reg. No. 56392-8 Dispatch® HospitalDisinfectant Towels with Bleach

Page 8 of 18

Acute care facilitiesAirplanesAnesthesia Rooms [Areas][Assisted Living] [Full Care] Nursing HomesBarsBathroom[s][Bed] Head [Foot] BoardBedroom[s]Blood BanksBowling AlleysBP MonitorsButcher ShopsCafeteriasCAT Laboratories]Central Service AreasCentral Supply [Rooms] [Areas]Chemotherapy HoodsChurchesColleges[Commercial] [Institutional] KitchensCorrectional Facilities[Critical Care Units] [CCUs]Day Care CentersDelisDental OperatoriesDialysis ClinicsDining Hall -or- Room[s]Dormitories

Use Sites/Surfaces:

[Emergency Medical] Transport VehiclesFactoriesFast Food [Chains] [Restaurants]Food [Service] [Processing] EstablishmentsFood Preparation and Processing AreasFood Serving AreasFootboardsFuneral HomesGrocery Stores[Gymnasiums] [Gyms]HeadboardsHealth Care [Settings] [Facilities]Health Club FacilitiesHome Healthcare [Settings][Hospital] KitchensHotelsIndustrial FacilitiesIV StandsKitchen[s]LaundromatsLaundry RoomsLocker RoomsManufacturing [Plants] [Facilities][Mayo] [Instrument] Stands[Medical] ClinicsMedical FacilitiesMilitary InstallationsMotels

Nurse Call Device [and Cord]Nurse-Call [Device] [Button] [and Cord][Nursing] [Nurses'] StationsOrthopedicsOther Food Service EstablishmentsOutpatient ClinicsPatient RestroomsPatient Rooms[Pediatric] [Examination Rooms] [Areas]PharmaciesProduce AreasPublic AreasRecreational [Centers] [Facilities]Respiratory [Therapy Rooms] [Areas]Restaurants[Restrooms] [Restroom] AreasSchool BusesSchool KitchensSchoolsSheltersShower RoomsSill[s] Ledge[s]Storage [Rooms] [Areas]Supermarkets[Surgery Rooms] [Operating Rooms] [ORs]Trains[TV] Remote[s] [Control] [s]Universities

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N ote: Bold, italicized text is information for the re( nd is not part of the label.[Bracketed information is optional text.] GreerK..Berimed text is new. Strike-through(text) means removed. Optional text may be placed anywhere on the label/container.R0887059_clean_Rosie


Page 9 of 18

any washable (food and non-food contact)surface where

disinfection is requiredappliance exteriors[bath]tubs[bathroom] fixturesbed pansbed rails/railing[bedside] commodes -or- tablesbedframesbehind and under countersbehind and under sinksbooster chairscabinet [handle]sceilingscloset handlescoated mattressescoated pillows[computer] monitors[dental] countertopsdental operatory surfaces[dentist] [dental] chairsdesk topsdesks[diaper] [infant] changing tablesdiaper pailsdictating equipment [surfaces]dish racksdoorknobsdrain boards[exam] [examination] tables

Use Sites/Surfaces (continued):

[exterior surfaces of air vents][air vent exteriors]

[exterior] [external] toilet surfaces[exterior] [external] urinal surfaces[external surfaces of [medical] equipment][[medical] equipment

surfaces]external [surfaces of] ultrasound .

transducers!**]glucometer exteriorsfaucetsfloorsfood casesfood traysfreezers[garbage] [trash] cans[grocery store] [supermarket] cartshampershand railingshard, nonporous [environmental] [hospital][medical] surfaceshard, nonporous [environmental] dentalsurfacesheadsetshigh touch surfaceshighchairshoods[hospital] [patient] [bed railings] [linings][frames][inner] [inside of] drawerslamps

light lens coverslinoleummed[ication] cartsmicrowave exteriorsother telecommunications equipment

[surfaces]outdoor furniture (excluding wood framesand upholstery)oven exteriorspatient chairsphone cradlepipesplaypensreception [counters] [desks] [areas]refrigerator exteriorssalad bar sneeze guardsshelvesshower walls[showers] [shower stalls]sinksstall doorssupport barstables[telephones[tiled] wallstoilet seats -or- rimstowel dispensers[vanity tops] [vanities]wash basins


Note: Bold, italicized text is information for thereau*r and is not part of the label.[Bracketed information is optional text.] Green underlined text is new. Strike-through(text) means removed. Optional text may be placed anywhere on the label/container.R0887059_clean_Rosie

r EPA Reg. No. 56392-8 Dispatch® Hospital IDisinfectant Towels with Bleach

Page 10 of 18

Additional Surfaces:

acrylic glass[baked] enamel[common] hard, nonporous

[household] [environmental]surfaces

Formica[®]2

glassglazed ceramic tilehard plasticslaminated surfacesMarlite[®]3plastic [laminate]

porcelain enamelstainless steelsynthetic marblevinyl [tile]

2Formica is a [registered] trademark of [The Diller Corporation] [a subsidiary of] [Formica] [Formica Corporation][or one or more of its affiliates].

sMarlite is a [registered] trademark of [Marlite, Inc.] [a subsidiary of] [Marlite, Inc.] [or one or more of its affiliates].

aluminumbrasschipped enamelchrome

Not Recommended

clear plasticclothescopperfabric

For Use On -or- Avoid Contact With:

natural marblepainted surfacespaper surfacesrubber

sealed granitesilver[unfinished] wood


Note: Bold, italicized text is information for the rea.. jnd is not part ol the label.[Bracketed information is optional text.] Green underlined text is new. Strike-through(tert) means removed. Optional text may be placed anywhere on the label/container.R0887059_clean_Rosie

EPA Reg. No. 56392-8 Dispatch® Hospital Cleane1


fa/2/iner I '

Addendum to DISPATCH® Hospital Cleaner Disinfectant Towels with Bleach(EPA Reg. No. 56392-8) to Support Home Healthcare Labeling

The addendum to the master label includes the information that will appear on home healthcare labeling. The kits will include homehealthcare products such as the following: personal care products (e.g. hand sanitizers and antimicrobial hand soap); caregiver protection(e.g. gloves, masks, and gowns); other cleaners or antimicrobial pesticides. The kits will be marketed for various home healthcare needs,such as "Germ Disinfection Kit", "Home Care Clean-Up Kit."

FRONT PANEL

• Kit Name (ABN to be submitted)• Product Name (ABN to be submitted)• Signal Word — Highest category signal word for the products in the kit

on front panel; product specific signal word on back/side panel)• Referral to Side/Back Panel for Additional Precautionary Statements• Keep Out of Reach of Children Statement• Net Weight/Net Contents

B SEE BACK PANEL FOR ADDITIONALQ PRECAUTIONARY STATEMENTS.

0VEA EL PANEL POSTERIOR PARAI 0 DECLARACIONES PREVENTIVAS ADICIONALES.

Si usted no entiende la etiqueta, busque a alguien para que se la explique a listed en detalle.

Kit Contents including, but not limited to, the following:

" 1

10

SIDE/BACK PANEL

Product Section:• Product Name (ABN to be submitted)• EPA Registration Number• Ingredient Statement• Signal Word• Precautionary Statements• First Aid Statements• Referral to Read the Labels on the Containers

in the Kit for Full Directions for Use

Clorox® CareConceptsBroad Spectrum DisinfectingBleach WipesEPA Reg. No. 56392-8. EPA Est. No. 8251 -OH-1.

ACTIVE INGREDIENT:Sodium Hypochlorite 0.65%OTHER INGREDIENTS: 99.35%TOTAL: 100.00%

DIRECTIONS FOR USE: It is a violation ofFederal law to use this product in a mannerinconsistent with its labeling. See product label forDirections for Use.PRECAUTIONARY STATEMENTS: HAZARDS TOHUMANS AND DOMESTIC ANIMALS.

CAUTION: Causes moderate eye irritation.Avoid contact with eyes or clothing. Washthoroughly with soap and water after handling andbefore eating, drinking, chewing gum, usingtobacco, or using the toilet. FIRST AID: If in eyes,hold eye open and rinse slowly and gently withwater for 15-20 minutes. If present, removecontact lenses after the first 5 minutes of rinsing,then continue rinsing eye. Call a poison controlcenter or doctor for further treatment advice. Have .the product container or label with you when callinga poison control center or doctor, or going fortreatment. Poison Control Center: (800) 446-1014.CHEMICAL HAZARDS: Do not use this product withammonia or acids such as vinegar, rust removers ortoilet bowl cleaners.

GENERAL/COMPANY INFORMATION SECTION

• Name/Address of Producer or Registrant• EPA Establishment Number

Mfg. for Clorox Professional Products Company, Distributed by The Clorox Company1221 Broadway, Oakland, CA94612.Clorox is a registered trademark of The Clorox Company.CareConcepts is a trademark of The Clorox Company.®2013 Made in the USA.EPA Est. No. XXXXX-XX-X (input final facility/co-packer for kit).


Note: Bold, italicized text is information (or the reau*, and is not part of the label.[Bracketed information is optional text.] Green underlined text is new. Strike-through(text) means removed. Optional text may be placed anywhere on the label/container.R0887059 clean Rosie


Page 12 of 18


The addendum to the master label includes the information that will appear on home healthcare labeling. The kits will include homehealthcare products such as the following: personal care products (e.g. hand sanitizers and antimicrobial hand soap); caregiver protection(e.g. gloves, masks, and gowns); other cleaners or antimicrobial pesticides. The kits will be marketed for various home healthcare needssuch as "Germ Kit" and "Clean-Up Kit."

KEEP OUT OF REACH OF CHILDRENCAUTIONNOT TO BE USED AS BABY WIPES -or-This is not a baby wipe [Not for personal use.]KEEP PACKAGE -OR- CONTAINER TIGHTLY SEALED WHEN NOT IN USERead Complete Directions and Precautions on Back -or- side -or- rear[Panel[s]] [Dispenser Carton]SELECT A SIZE (For Canister Only)[Net] [Contents] [# of towels and size and weight]Each package type and size will bear the actual net contents inpounds and ounces

Active Ingredient:Sodium Hypochlorite 0.65%Other Ingredients 99.35%Total 100.00%(yields 0.62% available chlorine)

• [Contains 6500 ppm Sodium Hypochlorite]• [Pre-Moistened Towels with 1:10 Dilution

of Bleach [(6.0%)] and Detergent]

Questions or Comments? Call (800) 492-9729 or visit us at www.[insert website].com.Mfd. for Clorox Professional Products Company, Distributed by The Clorox Company.1221 Broadway, Oakland, CA94612.A list of this product's ingredients is available at www.lngredientslnside.com -or-A list of [this product's] [product name] ingredients is available at[insert company website].Clorox -and/or- CareConcepts is -or- are a registered trademarks] of The Clorox Companyinsert trademark is a [registered] trademark of The Clorox Company

EPA Reg. No. 56392-8EPAEst. No. 8251-OH-1 (Q6);5813-GA-2(VG);IL-2(VF)Beginning of batch code indicates Est. No.

PRECAUTIONARY STATEMENTS: Hazards to humans and domestic animals.CAUTION:Causes moderate eye irritation. Avoid contact with eyes or clothing. Wash thoroughly with soap and water after handling and before eating,drinking, chewing gum, using tobacco, or using the toilet.

FIRST AID:If in eyes, hold eye open and rinse slowly and gently with water for 15-20 minutes. If present, remove contact lenses after the first 5 minutesof rinsing, then continue rinsing eye. Call a poison control center or doctor for further treatment advice. Have the product container or labelwith you when calling a poison control center or doctor, or going for treatment. [Emergency Information: 1-800-446-1014. -or- Poison ControlCenter: (800) 446-1014 -or- Clorox Information Line: 1-888-797-7225 -or- Questions? Call 1-888-797-7225.]PHYSICAL OR CHEMICAL HAZARDSDo not use this product with ammonia or acids such as vinegar, rust removers, or toilet bowl cleaners.

STORAGE AND DISPOSAL:For soft packs and individually wrapped packsStore this product in a cool, dry area away from direct sunlight and heat. Nonrefillable container. Do not reuse or refill this container. Discardused towel and empty package in trash. [Do not flush towels down toilet.]


fNote: Bold, italicized text is information (or the real,-, jnd is not part of the label.

[Bracketed information is optional text.] Green underlined text is new. Strike-through(text) means removed. Optional text may be placed anywhere on the label/container.R0887059_clean_Rosie

rEPA Reg. Mo. 56392-8 Dispatch® Hospital Cleanet



The addendum to the master label includes the information that will appear on home healthcare labeling. The kits will include homehealthcare products such as the following: personal care products (e.g. hand sanitizers and antimicrobial hand soap); caregiverprotection(e.g. gloves, masks, and gowns); other cleaners or antimicrobial pesticides. The kits will be marketed for various home healthcare needssuch as "Germ Kit" and "Clean-Up Kit."

Packaging Related Statements

For fold-pack labels:Peel for [here] [additional] directions [for use][.]

Soft pack directionOpen package. Pull out wipes as needed and reseal. When not in use keep sealed to prevent moisture loss. Gloves should be worn.

Individually wrapped Pack directionsTear open packet. Unfold and use as directed. Discard after single use. Gloves should be worn.RESEAL HEREPULL TABRemove [flaps] [lid] to create dispenser.

Optional graphics. May be placed anywhere on "Home Healthcare" kit carton/labeling, label/container or ABN.

PAPER

[Not for personal use.:GAIIE,

[[Use your phone to] go here -and/or- scan [[the] tag

~°r~ ^ ^ C0t^ l° '^^ ~°r" ^ ~°r~ S6e [m°re] US6S ~0r~information [on how-to-use [This Produc(\] -or- [how-to]tips -or- [how-to [-use]] videos] [(Data rates may apply)]

CAREC O N C E P T S "

R0887059_c1ean_Rosie.indd 13 7/24/13 5:37 PM

fNote: Bolt}, italicized text is information for the reati*. <ind is not part of the label.[Bracketed information is optional text.] Green underlined text is new. Strike-through(text) means removed. Optional text may be placed anywhere on the label/container.R0887059_clean_Rosie


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DIRECTIONS FOR USE:It is a violation of Federal Law to use this product in a manner inconsistent with its labeling.

To Clean, Disinfect, and Deodorize in One Step: Wipe surface with towel until completely wet. Let stand for one minute. [To kill TB, let standfor two minutes at room temperature (20 - 25°C -or- 68 - 77° F).] Wipe dry or allow to air dry. Gross soil must be removed prior to disinfecting.Gloves should be worn.

To Clean: Follow directions above, but no standing time is required. If streaking is observed, wipe with a clean, damp cloth or paper towel.

To be used for collateral material

•Wipe surface[s] to be disinfected [and deodorized] with [the](insert ABN) -or- this product until completely wet. Let standfor one minute. Wipe dry or allow to air dry. Gross soil must beremoved prior to disinfecting. Gloves should be worn.

-or-• Wipe surface[s] to be disinfected [and deodorized] with [the](insert ABN] -or- this product. Refer to [product] label fordirections for use and precautionary statements.

NOTE JO REVIEWER: This statement to be used on labels with medical devices used in home healthcare settings:

**This product is not to be used as a terminal sterilant/high level disinfectant on any surface or instrument that (1) is introduced directly intothe human body, either into or in contact with the bloodstream or normally sterile areas of the body, or (2) contacts intact mucous membranesbut which does not ordinarily penetrate the blood barrier or otherwise enter normally sterile areas of the body. This product may be used topreclean or decontaminate critical or semi-critical medical devices prior to sterilization or high level disinfection.


Note: Bold, italicized text is information for the n^ and is not part of the label.[Bracketed information is optional text.] Greeri'uhderlined text is new. Strike-through(text) means removed. Optional text may be placed anywhere on the label/container.R0887059_clean_Rosie

r EPA Reg. No. 56392-8 Dispatch® Hospital CleanerDisinfectant Towels with Bleach

Page 15 of 18


The addendum to the master label includes the information that will appear on home healthcare labeling. The kits will include homehealthcare products such as the following: personal care products (e.g. hand sanitizers and antimicrobial hand soap); caregiver protection(e. g. gloves, masks, and gowns); other cleaners or antimicrobial pesticides. The kits will be marketed for various home healthcare needssuch as "Germ Kit" and "Clean-Up Kit."

The following claims are to be used on the home healthcare labeling, "HomeHealthcare" ABN of this product label and/or theeducational kit insert.

The kits will include home healthcare products and educational material such as the following:hand sanitizers and antimicrobial hand soap; personal protective equipment (i.e. gloves, masks and gowns); other cleaners orantimicrobials; and an educational insert for the products mentioned along with information for proper home healthcare hygiene.

General/Non-pesticidal Claims

• Advanced cleaning formula• Be ready• Care -or- caregiving concepts• Cleaning made easy• Clean Home• Cleaning• Cleans the toughest soils• Cleans tough messes• Clorox® clean• Contains [Clorox®] bleach1 Contains no abrasives, harsh acids• Cuts cleaning time• Deep cleaning] [formula]• Delivers a clean you can see and smell• Designed for Home Healthcare -and/or- patients -and/or-

caregivers• Designed -or- developed for Home Caregivers• Designed -or- developed for use in Home Healthcare -or- Home

Care• Designed to be used around -or- for care of -or- in the care of

Immune-compromised -or- chemotherapy patients -or- individuals• Designed to be used around -or- for care of -or- in the care of thosewith weakened immune systems -or- hospital-acquired infections.

• Dries quickly1 Easy to use• Effectively removes everyday soils• Eliminates odors from fecal matter and urine• For a cleaner, fresher household• For more advice -or- tips -or- education -or- support -or-

information) visit us at www.(insert website).com• For more advice -or- tips -or- education -or- support -or-

information) call us [toll free] at (insertphone number)• For more advice -or- tips -or- education -or- support -or- information)visit us at our Facebook page at www.(//wert website).com

• For more advice -or- tips -or- education -or- support -or-information) visit us at \N\N\N .(insert website).com

• [For] Surface [care]• [For] Surface cleaning• For Use by Home Caregivers

• For Use in Home Healthcare• [Formulated -or- Designed to] remove[s] biological odors including

Urine -and/or- Feces -and/or- Vomit• Freshens• Great for everyday use• Great for use around the home• (Insert product Brand, e.g. Clorox®) is a new line of home

caregiving product and practical resources. Kits are available forthe most common caregiving needs [as well as refill-and/or-replenishment items.]

• [Kit] Contains care giver protective items [gloves -and/or- masks-and/or- gowns]

• Leaves a fresh bleach scent• Leaves nothing behind• Lightly scented -or- quick-dissipating scent• Making home healthcare more manageable -or- easier -or- simpler• Maximum cleaning, minimum effort• Moist wipes• Multi-purpose• Multi-surface• Neutralizes odors [doesn't [just] mask]• No harsh chemical odors or fumes• Non-abrasive formula• Powers through tough messes• Removes [tough] stains• Starts cleaning on contact• Strong cleaning power• Usable on a variety of soils• Use of this product does not produce mist in the air.•We're there for you• Works on -or- effective against -or- removes the following stains

-and/or- soils:

Stains/Soils:

Bodily FluidsBody oilsCommon soilsDead skinDefecationFecal matter

FecesFood StainsGrimeMucusPhlegmProtein-based

matterSalivaSpitSpittleSputumStool

Throw-UpUrineVomit

R0887059_dean_Rosie.indd 15 7/24/13 5:37 PM

Note: Bold, italicized text is information for the readeit _.... is not part of the label.[Bracketed information is optional text.] Green underlined text is new. Strike-through(text) means removed. Optional text may be placed anywhere on the label/container.R0887059 clean_Rosie


Page 16 of 18



Use Sites/Surfaces:

[For use on hard, non porous surfaces [such as]]:

acrylic glassappliance exteriorsbathroom[s]bed rails/railingbedroomfs][bedside] commodes -or- tablesbedframesbrush handlescabinetscanescordscountertopscrutchesdiagnostic equipmentdining room[s]freezersFormica[®]2

glassglucometer exteriors

glazed ceramic tileglazed porcelaingrab barshard plasticshome[s]laminated plastic countertopslight switchesliving room[s]Marlite[®]3nonporous vinyloven exteriorspainted surfaces[plastic] fly swattersplastic mattress coversPlexiglas[®]iportable bathroomsprescription container exteriors[PVC] tubesrefrigerator exteriors

remote control exteriors -or- back(not buttons)

respirators] [exteriors]rocking chairssafety railsscalesscooters (Avoid plug or charging port)

Note to reviewer: "(Avoid plug orcharging port) " is not optional text.

sealed fiberglass surfacesshower fixturesstainless steelstoolsstove exteriors -or- stovetop[telephones[tile] wallstoilet seats -or- rimswalkers

Surfaces: For use on hard, non porous surfaces such as stainless steel, glazed ceramic tile, hard plastics, nonporous vinyl, painted surfaces,glazed porcelain, sealed fiberglass surfaces, Plexiglas[®]1, laminated plastic countertops, and glass.

[This product [is] not intended for use on fabrics.]

iRIexiglas is a [registered] trademark of [Arkema, Inc.] [a subsidiary of] [Arkema, Inc.] [or one or more of its affiliates],2Formica is a [registered] trademark of [The Diller Corporation] [a subsidiary of] [Formica] [Formica Corporation][or one or more of its affiliates].3Marlite is a [registered] trademark of [Marlite, Inc.] [a subsidiary of] [Marlite, Inc.] [or one or more of its affiliates].

aluminumbrasschipped enamelclear plasticclothes

Not Recommended For Use

chromecopperfabricnatural marblepainted surfaces

On -or- Avoid Contact With:

paper surfacesrubbersealed granitesilver[unfinished] wood


rNote: Bold, italicized text is information for the rea^ ^nd is not part of the label.[Bracketed information is optional text.] Green underlined text is new. Strike-through(text) means removed. Optional text may be placed anywhere on the label/container.R0887059_clean_Rosie


Page 17 of 18



"Home Healthcare Kit" Claims

The "Home Healthcare Kit" claims are to be used on the home healthcare labeling and/or the educational kit insert.

The kits will include home healthcare products and educational material such as the following:hand sanitizers and antimicrobial hand soap; personal protective equipment (i.e. gloves, masks and gowns); other cleaners orantimicrobials; and an educational insert for the products mentioned along with information for proper home healthcare hygiene.

Disinfecting/Pesticidal Claims:

• Antibacterial formula• [Bactericidal] [Tuberculocidal] [Virucidalft] [Fungicidal -or-

antifungal] [Sporicidal] [Disinfectant].• Broad Spectrum Disinfectant• [Cleans [and], Disinfects, [& Deodorizes] in One Step]• Demonstrated Effectiveness against [.insert organismls] from

page 18\ [on hard, nonporous surfaces -or- on (insert use site)]• Deodorizes• Disinfectant• [Efficacy tests have demonstrated that [Product Name] [this

product] [are] [is] an effective bactericide, virucideff, tuberculocide,and fungicide in the presence of organic soil (5% blood serum)]

• [Efficacy tests have demonstrated that [Product Name][this product] [are] [is] an effective bactericide, virucideff,tuberculocide, and fungicide in the presence of organic soil (5%blood serum)]

• [For] Disinfecting• [For] Germ Kill• Fungicidal -or- antifungal• Helps prevent patient-to-caregiver and caregiver-to-patient [cross-]

spread of germs• Helps reduce the spread of germs -or- bacteria -or- viruses -or-

pathogens [on hard, nonporous surfaces.]• Helps reduce the spread of germs -or- bacteria -or- viruses

-or- pathogens -or- insert organismls] from page 18 on hard,nonporous surfaces.

• [In circumstances of room contamination,] clean [room] fromcleanest to dirtiest surfaces, [and] [Clean] from highest to lowest[surfaces] [using (insert ABN) -or- this product to clean anddisinfect high-touch areas]

• (Insert product Brand, e.g. Clorox®) is a new line of productsand practical advice, [that includes help with killing germs] [thatmay be brought home from the hospital or outside], [when you arecaring for loved ones at home]. The disinfecting products included[are designed to] kill germs [and prevent the spread of germs] [onhard non-porous surfaces].

• [Kills [99.99% of] bacteria, virusesff & fungi in 1 Minute on Hard,Nonporous Surfaces]

• Kills [99.9% of] germs [on hard surfaces]• Kills a broad spectrum of [home] healthcare germs on hard

surfaces [in 1 min[ute]] [.insert organisms from page 18\• Kill[s] -and/or- Fights -and/or- Effective against germs that can

cause [home care] infections -or- illnesses [.insert organismls]from page 18\.

• Kill[s] -and/or- Fights -and/or- Effective against [-.insertorganismls] from page 18] [on hard, nonporous surfaces -or- on(insert use site)].

• Kills -or- Fights -or- is effective against [.insert organismls] frompage 18] [on hard, nonporous surfaces -or- on (insert use sitefrom page 16)

• Kills Pandemic 2009 H1 I\I1 influenza A virus [(formerly called swineflu)].

• Pay close attention to hot spots or frequently touched surfaces(insert use sites and surfaces) and disinfect regularly, up to 3times daily

• Prevents] the spread of [the most] [common] [home care] germs-or- pathogens

• Products -and/or- advice -and/or- care for preventing the spread ofcommon Home HealthCare germs.

• Products and [practical] advice -or- tips for [helping to]preventing] the spread of germs

• Solutions -and/or- disinfection products -and/or- support for- [helpingto] preventing] the spread of [the most] [common] home [health]care germs

• Solutions -and/or- disinfection products -and/or- support for [themost] [common] home [healthjcare germs

• Solutions -and/or- disinfection products -and/or- support for-[helping to]prevent[ing] patient-to-caregiver and caregiver-to-patient [cross-]spread of[the most] [common] home [healthjcaregerms

R0887059_clean Rosie.indd 17 7/24/13 5:37 PM

Note: Bold, italicized text is information for the rea*.,. and is not part of the label.[Bracketed information is optional text.] Green underlined text is new. Strike-through(text) means removed. Optional text may be placed anywhere on the label/container.R0887059 clean_Rosie


Page18of18



Disinfecting/Pesticidal Claims continued:

' Solutions -and/or- disinfection products -and/or- support forhomes with high risk of germ spread

• Solutions -and/or- disinfection products -and/or- support for killinggerms that can cause [home [health]care] infections -and/or-illnesses [-.insert organisms from page 18]

' Stopping the spread of germs is a common concern for thosecaring for an [ill] [or immuno-compromised] individual at home.Many ill or aging individuals have weakened immune systemsand heightened sensitivity to germ-causing infection. Certain drugtreatments, chronic diseases, hospital stays, open wounds, orother conditions may also contribute.

• Use (insert ABN) to clean and disinfect high-touch areas[.]

"HOME HEAL THCARE KIT":

Acinetobacter baumanni

Enterobacter aerogenes

Enterococcus faecalis

Extended Spectrum Beta-Lactamase (ESBL) producing Escherichia coli

tfHepatitis A Virus (HAV)

ttHerpes Simplex Virus (HSV-2)

fflnfluenza A Virus

Klebsiella pneumoniae

Methicillin Resistant Staphylococcus aureus (MRSA)

Multi-drug Resistant [(MDR)] Enterococcus faecium [MDR]

Mycobacterium bovis

ffNorovirus

Pseudomonas aeruginosa

ft/Respiratory syncytial virus (RSV)

ffRhinovirus 37

ffRotavirus

Salmonella enterica [tested as Salmonella choleraesuis] [(Salmonella)]

Staphylococcus aureus [(Staph)]

Trichophyton mentagrophytes

Vancomycin resistant Enterococcus faecalis (VRE)

Acinetobacter infection

Enterobacter infection

Enterococcus infection

Food-borne illness -or- gastroenteritis


Herpes Simplex 2 Virus

Flu

Klebsiella infection

MRSA Infection -or- Staph infection -or-Antibiotic-resistant Staph infection

Enterococcus infection

Tuberculosis

Norovirus, Food-borne illness -or- gastroenteritis

Pseudomonas infection

Common cold

Common cold

Gastroenteritis


Staph infection

Fungal infection, Athlete's Foot

Enterococcus infection•


OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTIONAug 14, 2013 · 372-5 UNITED STATES...

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Transcript of OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTIONAug 14, 2013 · 372-5 UNITED STATES...